NCT07471503尚未招募2 期
A Phase 2 Clinical Study of Gecacitinib in Peri-transplant Period of Hematopoietic Stem Cell Transplantation in Patients With Myelofibrosis (MF)
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 39
- 主要终点
- 1-year GVHD-free and relapse-free survival (GRFS) rate from the date of transplant
研究概览
简要总结
The investigators evaluate the efficacy and safety of Gecacitinib in patients with myelofibrosis (MF) before, during, and after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years, regardless of gender;
- •Diagnosis of primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV-MF), or post-essential thrombocythemia myelofibrosis (post-ET-MF) according to the 2022 WHO diagnostic criteria;
- •Meeting the criteria for intermediate-risk or high-risk groups per the DIPSS-plus classification;
- •Scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT), including transplants from HLA-matched or mismatched related or unrelated donors;
- •ECOG performance status ≤2 and Karnofsky performance status ≥60%;
- •Capable of understanding and signing the informed consent form, and able to comply with study and follow-up procedures.
排除标准
- •Patients using other JAK inhibitors (except for Gecacitinib) at the time of screening may be enrolled if they switch to Gecacitinib treatment prior to screening.
- •Patients who have previously undergone allogeneic hematopoietic stem cell transplantation or organ transplantation.
- •Disease progression to accelerated or blast phase (peripheral blood or bone marrow blast percentage ≥10% at any time prior to transplantation).
- •Presence of significant medical conditions or marked organ dysfunction that cannot be adequately controlled and may affect the completion of this study:
- •Congestive heart failure classified as New York Heart Association (NYHA) Class III-IV, or documented history of diastolic or systolic dysfunction (e.g., LVEF <40% measured by echocardiography), or uncontrolled or unstable angina or myocardial infarction.
- •Uncontrolled diabetes (>250 mg/dL or >13.9 mmol/L).
- •Hypertension that cannot be reduced to the following range despite combination antihypertensive therapy (systolic blood pressure <160 mmHg, diastolic blood pressure <100 mmHg).
- •Peripheral neuropathy (≥ Grade 2 per NCI-CTC AE v5.0 criteria).
- •Serum creatinine >1.5 × ULN.
- •ALT or AST >2.5 × ULN, or DBIL or TBIL >2.0 × ULN.
- •Patients with any bacterial, viral, or fungal infection not adequately controlled.
- •HIV-positive at screening, or active hepatitis B virus infection (HBsAg-positive with HBV-DNA positivity or above the normal reference range), or HCV antibody-positive with HCV-RNA positivity.
- •History of tuberculosis or positive interferon-gamma release assay at screening.
- •Suspected hypersensitivity to Gecacitinib Hydrochloride, drugs of the same class, or any of their excipients.
- •Pregnant or breastfeeding women, or patients unwilling to use effective contraception during Gecacitinib treatment and for one week after the last dose.
- •Patients with any other comorbidities that may interfere with the study or a history of prior malignancies.
- •Patients unable to take oral tablets.
研究组 & 干预措施
Gecacitinib treatment
Experimental
干预措施: Gecacitinib (also known as Jaktinib) (Drug)
结局指标
主要结局
1-year GVHD-free and relapse-free survival (GRFS) rate from the date of transplant
时间窗: 1 year post-HSCT
GRFS is defined as the absence of grade 3 to 4 acute GVHD, chronic GVHD requiring systemic immunosuppressive treatment, disease relapse, and death.
次要结局
- Cumulative incidence of aGVHD(+100 days and 6 months post-HSCT)
- Cumulative incidence of cGVHD(6 months and 1 year post-HSCT)
- The molecular relapse rate of MF(1 year post-HSCT)
- Non-relapse mortality (NRM) rates(6 months and 1 year post-HSCT)
- Rate of Engraftment(100 days post-HSCT)
- Proportion of patients with baseline splenomegaly achieving a ≥35% reduction in spleen volume.(100 days, 6 months, and 1 year post-HSCT)
- Overall Survival(1 year post-HSCT)
- Progression Free Survival (PFS)(1 year post-HSCT)
- Toxicity rate(From the first dose to 28 days after the last dose.)
研究者
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